MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿; COUNTER, DIFFERENTIAL CELL

Catalog Number 343202

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd facscalibur¿ that the device acquires everything seems fine but giving the result there are more t cells than leukocytes.Applications has spoken with her and it has not been clear that it is a problem of use.It has not been able to provide applications with dot plots to visually analyze the data.The following information was provided by the initial reporter the client says that when the device acquires everything seems fine but giving the result there are more t cells than leukocytes.Applications has spoken with her and it has not been clear that it is a problem of use.It has not been able to provide applications with dot plots to visually analyze the data.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.This was a qc failure not on patient samples, therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that while using bd facscalibur¿ that the device acquires everything seems fine but giving the result there are more t cells than leukocytes.Applications has spoken with her and it has not been clear that it is a problem of use.It has not been able to provide applications with dot plots to visually analyze the data.The following information was provided by the initial reporter the client says that when the device acquires everything seems fine but giving the result there are more t cells than leukocytes.Applications has spoken with her and it has not been clear that it is a problem of use.It has not been able to provide applications with dot plots to visually analyze the data.

• Brand Name: BD FACSCALIBUR¿
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15521423
• MDR Text Key: 306418341
• Report Number: 2916837-2022-00274
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K973483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 343202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1